Cardiac SurgeryNCT05225246
Readmissions After Cardiac Surgical Procedures
An observational study of Cardiac Surgery, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this study is to analyze the reasons for unplanned readmissions after cardiac surgery at the University Hospital Basel. Predictive factors for readmissions and the development over the last 10 years will be analyzed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Data collection on reasons for unplanned readmission to the University Hospital Basel within 30 days of leaving the hospital
- How many people
- 4,882 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Since January 2010, around 7,500 patients have had heart surgery, and around 2,083 of these patients have returned to the University Hospital of Basel within 30 days of discharge after heart surgery.
Who may be able to join
- Patients who had heart surgery and returned unplanned to the University Hospital Basel within 30 days of leaving the hospital (outpatient or inpatient)
- Patients who had heart surgery and did not return unplanned to the University Hospital Basel within 30 days of leaving the hospital (outpatient or inpatient)
Who cannot join
- Patients with other initial hospitalization reasons for heart surgery without heart surgery (conservative treatments, cerclage removal, pacemaker surgery) are not included in the analysis.
- Planned readmissions to the University Hospital Basel within 30 days
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Cardiac Surgery Clinic
Basel, 4031
About this study
The aim of this study is to analyze the reasons for unplanned readmissions after cardiac surgery at the University Hospital Basel. Predictive factors for readmissions and the development over the last 10 years will be analyzed.
- Conditions
- Cardiac Surgery
- Being tested
- Data collection on reasons for unplanned readmission to the University Hospital Basel within 30 days of leaving the hospital
- Keywords
- hospital readmission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection on reasons for unplanned readmission to the University Hospital Basel within 30 days of leaving the hospitalOther
Descriptive analysis of the reasons for unplanned readmissions after cardiac surgery and predictive factors for unplanned readmissions and validation of risk scores
| Study group | Role | What they receive |
|---|---|---|
| Readmission group | Patients who had heart surgery and returned unplanned to the University Hospital Basel within 30 days of leaving the hospital (outpatient or inpatient) Receives: Other: Data collection on reasons for unplanned readmission to the University Hospital Basel within 30 days of leaving the hospital | |
| control group | Patients who had heart surgery and did not return unplanned to the University Hospital Basel within 30 days of leaving the hospital (outpatient or inpatient) Receives: Other: Data collection on reasons for unplanned readmission to the University Hospital Basel within 30 days of leaving the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cardiac related readmissions compared to infections, bleedings and neurological causes
Number of cardiac related readmissions compared to infections, bleedings and neurological causes
Measured: one time assessment at baseline
Sex specific reasons for readmissions
Differences in sex specific reasons for readmissions
Measured: one time assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Sep 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,882 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Reuthebuch, Prof. Dr. med., Principal investigator, University Hospital Basel, Cardiac Surgery Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225246
- Sponsor's protocol ID
- 2020-02023; kt22Reuthebuch
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2022
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Readmissions After Cardiac Surgical Procedures
- ClinicalTrials.gov ID
- NCT05225246
- Acronym / sponsor ID
- 2020-02023; kt22Reuthebuch
- Conditions
- Cardiac Surgery
- Keywords
- hospital readmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,882 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to analyze the reasons for unplanned readmissions after cardiac surgery at the University Hospital Basel. Predictive factors for readmissions and the development over the last 10 years will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Readmission group | – | Other: Data collection on reasons for unplanned readmission to the University Hospital Basel within 30 days of leaving the hospitalPatients who had heart surgery and returned unplanned to the University Hospital Basel within 30 days of leaving the hospital (outpatient or inpatient) |
| control group | – | Other: Data collection on reasons for unplanned readmission to the University Hospital Basel within 30 days of leaving the hospitalPatients who had heart surgery and did not return unplanned to the University Hospital Basel within 30 days of leaving the hospital (outpatient or inpatient) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Since January 2010, around 7,500 patients have had heart surgery, and around 2,083 of these patients have returned to the University Hospital of Basel within 30 days of discharge after heart surgery.
Key inclusion criteria (2 listed)
- Patients who had heart surgery and returned unplanned to the University Hospital Basel within 30 days of leaving the hospital (outpatient or inpatient)
- Patients who had heart surgery and did not return unplanned to the University Hospital Basel within 30 days of leaving the hospital (outpatient or inpatient)
Key exclusion criteria (2 listed)
- Patients with other initial hospitalization reasons for heart surgery without heart surgery (conservative treatments, cerclage removal, pacemaker surgery) are not included in the analysis.
- Planned readmissions to the University Hospital Basel within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection on reasons for unplanned readmission to the University Hospital Basel within 30 days of leaving the hospitalDescriptive analysis of the reasons for unplanned readmissions after cardiac surgery and predictive factors for unplanned readmissions and validation of risk scores | Other | Readmission group, control group |
Primary outcome
Number of cardiac related readmissions compared to infections, bleedings and neurological causes
Time frame: one time assessment at baseline
Number of cardiac related readmissions compared to infections, bleedings and neurological causes
Sex specific reasons for readmissions
Time frame: one time assessment at baseline
Differences in sex specific reasons for readmissions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Reuthebuch, Prof. Dr. med. principal investigator
University Hospital Basel, Cardiac Surgery Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cardiac related readmissions compared to infections, bleedings and neurological causes (time frame: one time assessment at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.